You're listening to the Anesthesia Patient Safety Podcast , the official podcast of the Anesthesia Patient Safety Foundation . We're bringing you the very best from the APSF newsletter and website , as well as the latest information in perioperative patient safety . Thanks for joining us .
Hello and welcome back to the Anesthesia Patient Safety Podcast . My name is Allie Bechtel and I'm your host . Thank you for joining us for another show . We hope you tuned in last week when we kicked off the conversation about the devastating recurrent wrong drug , wrong route error of inadvertent intrathecal tranexamic acid administration .
This is part two today and we will be discussing a multi-stakeholder approach to addressing this devastating patient safety issue . This devastating patient safety issue . Before we dive into the episode today , we'd like to recognize ICU Medical , a major corporate supporter of APSF .
Icu Medical has generously provided unrestricted support to further our vision that no one shall be harmed by anesthesia care , vision that no one shall be harmed by anesthesia care . Thank you , icu Medical . We wouldn't be able to do all that we do without you . Our featured article again today is from the June 2024 APSF newsletter .
It is Unraveling a Recurrent Wrong Drug , wrong Route Error Tranexamic Acid in Place of Bupivacaine A Multi-Stakeholder Approach to Addressing this Important Patient Safety Issue by Elizabeth Ribello and colleagues . To follow along with us , head over to apsforg and click on the newsletter heading First .
One down is the current issue and click on the newsletter heading First . One down is the current issue . From here , scroll down until you get to our featured article today . I will include a link in the show notes as well . Last week , we reviewed a case of inadvertent TXA administration in the intrathecal space instead of bupivacaine .
Intrathecal TXA is a neurotoxin that can cause neurological injury , seizures , paraplegia , ventricular fibrillation and death . Over 50% of TXA-associated intrathecal injections result in death or harm . We are going to talk about considerations to help prevent this error in more detail today .
The single most effective measure to reduce this drug error is to supply tranexamic acid in pre-mixed bags only Human factors . Analysis of this wrong drug , wrong route event has revealed that mistaking lookalike TXA ampules or vials for local anesthetic ampules or vials was the main cause of these events .
It is alarming that this event continues to occur , so let's dive into prevention strategies so that we can help to keep our patients safe during neuraxial anesthesia care . The APSF Stolting Conference in 2010 was dedicated to medication safety and resulted in recommendations for new strategies for predictable , prompt improvement of medication use in the OR .
Many of these 2010 recommendations have not been widely implemented . One such recommendation was that routine provider-prepared medications should be discontinued whenever possible and that high-alert medications like tranexamic acid should be prepared by the pharmacy in ready-to-use bolus or infusion form that is appropriate for both adult and pediatric patients .
Check out figure 1 in the article to see the hierarchy of effectiveness for risk reduction strategies when it comes to preventing drug errors , from least effective to most effective . That was created by the ISMP or the Institute for Safe Medication Practices .
Starting at the bottom of the figure , we have the strategies that are least effective and the easiest to implement . These include suggestions , to quote be more careful , providing available information , education programs , rules and policies . These four strategies are in the low leverage group and are related to human reliability .
The next group is the medium leverage group , which includes warnings , alerts , reminders and checklists , redundancies , and standardizations and protocols . These are more effective and a little harder to implement and span from human reliability to system reliability . At the top of the figure are the three strategies that are most effective and the hardest to implement .
These high-leverage strategies are related to system reliability and include automation and computerization , barriers and fail-safes and forcing function . I will include this figure in the show notes as well . We know that the interventions at the bottom of the figure that rely on humans have some benefits but are less effective than system-focused high-leverage options .
Let's look at an example of a forcing function and fail-safe option . In Japan there has been adoption of the NR-Fit neuraxial connectors , which are designed to prevent misconnections and prevent wrong delivery of medications in the neuraxial space . Using NR-Fit neuraxial connectors was possible with advocacy from the Japan Ministry of Health , labor and Welfare .
In the United States , efforts to adopt these connectors has not been successful . What if we apply the ISMP's most effective risk reduction strategies to the problem of TXA-associated intrathecal errors ? We can use barriers and forcing functions to help prevent this error .
The first step would be to eliminate or significantly restrict TXA vials and ampoules and only allow manufacturer-prepared ready-to-administer TXA 1,000 mg per 100 ml bags or pharmacy-prepared IV bags . This strategy creates a constraint to avoid the lookalike problem with local anesthetics and TXA . This sounds like such an easy and simple solution to such a big problem .
It is also not a new concept to remove vials of medication that cause significant patient harm from patient care areas . In the 1990s , vials of medication that cause significant patient harm from patient care areas . In the 1990s , vials of concentrated potassium chloride could be found in patient care units .
Following patient deaths from administration of concentrated potassium chloride , a national movement resulted in removing the concentrated vials and making sure that only dilute potassium chloride would be allowed in patient care units . We have an opportunity here to remove TXA vials and ampoules from patient care areas to help keep patients safe .
Let's take a look at the medico-legal perspective when it comes to this medication error . The authors report that medical malpractice claims resulting from medication errors are indefensible from a standard of care perspective . The claims are made against the responsible clinicians , as well as negligence claims against the facilities .
This may occur when there is evidence or testimony that the medication error occurred due to the facility prioritizing labor efficiencies or other cost-saving measures over patient safety . Often , these measures taken by the facility can lead to decreased patient safety and increased facility cost .
Patients and families may seek millions of dollars in damages for medical errors that result in brain damage or death , especially when patients require ongoing medical care or are unable to return to work . Another important consideration is that clinicians involved in medication errors may undergo civil litigation as well as licensing board investigations and criminal charges .
The licensing board may initiate formal disciplinary action against the clinician following a medication error . The facility where the medication error occurred may undergo investigation from regulators and accrediting bodies , which can have a significant financial cost as well as impact the reputation of the facility .
Clinicians must feel safe to report near misses and medication errors and to review systems issues in the department and hospital and institution in a non-punitive way . This is a requirement for improved patient safety .
It is also important to have a system for providing confidential peer support when an event occurs , to help reduce the long-term negative impact , with the clinician as the second victim .
Peer review protections depend on state law , which means that for a hospital to engage in appropriate and necessary systems review following a medication error event , it depends on the hospital's location .
The authors offer a call to action for policymakers in states without these protections to work towards the adoption of laws that will allow facilities to perform appropriate confidential peer review practices , with clinicians who are free to review and discuss clinical care without fear of litigation and disciplinary action .
A system of reporting and reviewing medication errors is a crucial step for decreasing future adverse events , encouraging continued reporting and improving patient safety . Next up , we are going to talk about the manufacturer's perspective . Next up , we are going to talk about the manufacturer's perspective .
There may be many suppliers for a particular drug , which helps to ensure a strong supply of medication in the market , but it may lead to differences in the appearance of the product . As a result of these variable appearances , there's a higher potential for lookalike medications . Did you know that there are 13 companies that manufacture TXA for the US market ?
In the US , you can find TXA stored in vials , pre-mixed bags and ampoules . Eight companies manufacture bupivacaine , which you can find in vials for the most part and a very small percentage of ampoules .
There is a responsibility for manufacturers to understand how drugs are stored and use this when they make packaging and labeling decisions , especially when products are stored together and are incredibly high risk , such as this case with TXA and bupivacaine . Manufacturers can also help improve medication safety by offering ready-to-administer products .
Now that there are ready-to-administer infusion bags of TXA 1000 mg per 100 ml bags available , there is a realistic and achievable way to prevent future TXA bupivacaine drug errors . Ready-to-administer products are recommended by major scientific and regulatory organizations , including the Joint Commission .
This is an important step for improved medication safety , since pre-mixed bags and pre-filled syringes do not require assembly at the patient's bedside just prior to administration . Using ready-to-administer products eliminates the medication preparation steps where errors may occur .
Another benefit of FDA-approved , manufacturer-prepared ready-to-administer products is that the label contains all the required information and a barcode to help verify the proper drug and dose prior to administration .
To help ensure safe drug delivery , the FDA has a rigorous approval process for manufacturers who want to provide combination products , and there are a select number of manufacturers who have this manufacturing capability .
There is a growing number of ready-to-administer products , which is a pivotal advancement in medication delivery and an important step for improving medication safety going forward . So what can we do to prevent this devastating wrong drug , wrong route , medication error ?
We need to make sure that TXA is only available in a pre-mixed bag rather than a vial form in the perioperative environment . This provides the necessary forcing function and barrier to ensure safe medication delivery and is the single most effective intervention .
Let's take a look at some additional recommendations from the 2024-2025 ISMP Targeted Medication Safety Best Practices . Use barcode-assisted medication safety checks , if available , when preparing and prior to administering medications in surgical and obstetrical areas . Develop protocols to use pre-mixed intravenous bags of TXA or pharmacy-prepared infusion bags to prevent mix-ups .
Foster a culture of safety . Maintain a high level of vigilance when these two medications are given during a case . Meet with key stakeholders to review their workflow when ordering and administering TXA to ensure safe practices . Evaluate workload to ensure workload pressures will not result in unsafe workarounds and practices .
Report near misses and unsafe medication practices and conduct regular reviews and discussions of medication events and close calls reported in your institution . The authors conclude with the call to action that for changes must be made to help prevent wrong drug , wrong route , medication errors .
While TXA needs to be available in the perioperative areas , the vials or ampoules should be removed completely and replaced with ready-to-administer 100 ml bags from the manufacturer or from a 503b compounding facility or the institution's pharmacy .
The cost of these pre-mixed bags is a small price to pay compared to the cost of a medication error that has such a high morbidity and mortality . So what are you waiting for ? The time to act is now . Before we wrap up for today , we are going to hear from Marbella again . I also asked her what she hopes to see going forward . Here is her response .
Going forward . It is important to employ strategies which force functions and create barriers to prevent this wrong drug , wrong route error . Having TXA available only in a pre-mixed bag rather than a vial or ampoule in the preoperative environment is the single most effective way to reduce this error . There are three ways to accomplish this measure .
One , have the medication drawn into a bag by your hospital pharmacy from the vial . Two , have this medication provided in a bag from a compounding pharmacy , a 503B compounding pharmacy . Or three , have a manufacturer-prepared bag of TXA . It's important to recognize the benefit of replacing the TXA vial with a pre-mixed bag .
This single measure could save a patient's life and also eliminate the devastating impact a medication error has on an anesthesia professional who may carry the burden of guilt their entire career .
Thank you so much to Rubello for contributing to the show today . We're looking forward to a future where TXA can only be found in pre-mixed ready-to-administer bags in the perioperative environment bags in the perioperative environment . If you have any questions or comments from today's show , please email us at podcast at apsforg .
Please keep in mind that the information in this show is provided for informational purposes only and does not constitute medical or legal advice . We hope that you will visit aSForg for detailed information and check out the show notes for links to all the topics we discussed today . The APSF has another great resource the APSF Video Library .
We've talked about the all-new fire safety video before , but there are other videos that you can check out . The Medication Safety in the Operating Room Time for a New Paradigm is an 18-minute long video that was released in January of 2012 , and it is intended for everyone who works in the operating room during surgery .
Head over to APSForg and click on the Patient Safety Resources heading . The fourth one down is the APSForg and click on the Patient Safety Resources heading the fourth one down is the APSF video library and then scroll down until you get to the Medication Safety video .
We hope that you will watch this video and share it with your anesthesia surgery and nursing colleagues or , better yet , watch it all together to help keep patients safe from medication errors in the operating room . Until next time , stay vigilant so that no one shall be harmed by anesthesia care .